Senior System Engineer

Hello! Our San Diego Pharmaceutical client is actively searching for a Senior System Engineer on a contract (to hire) term.

• Established IT partner supporting QA, Manufacturing, and Process Development teams.
• Demonstrated ability to deliver comprehensive end-user support with a high level of energy and professionalism.
• Direct experience providing technical assistance for GxP?regulated applications utilized in QA, Manufacturing, and Process Development settings. In-depth knowledge of 21 CFR Part 11, including proficiency in evaluating system changes for validation impact and facilitating revalidation activities such as IQ/OQ:
• Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP).
• Active involvement in Computer System Validation (CSV) procedures including:
• • User Requirements Specifications (URS)
• • Functional and Design Specifications
• • Support for IQ/OQ/PQ execution
• Proven background in the life sciences sector, particularly with authoring and updating SOPs for Information Technology.
• Experience preparing and managing change control documentation.
• Skilled at operating within cleanrooms and manufacturing areas.
• Strong understanding of network architecture, including subnets and WiFi.
• Familiarity with Manufacturing 3.0 concepts, including electronic batch records and IoT integration.
• Advanced proficiency collaborating with software vendors for Tier 2 and Tier 3 troubleshooting support.
• Established record of success with Help Desk ticketing systems.
• Technical expertise in desktop support at Tier 2 and Tier 3 levels.

Systems Experience:

• Proficient with M365 platform user support, including admin settings, SharePoint, MS Office, Outlook, Copilot, Power Automate, and basic shell scripting.
• Shopfloor control systems: Chromatography (AKTA/Unicorn), instrument control (Cytiva/Thermofisher equipment, DeltaV).
• Familiar with MES, LIMS, ERP (S/4 Hana or QAD), CRM admin (Salesforce), QMS (Veeva/Master Control), BMS (Siemens/Desigo), asset & calibration systems (Blue Mountain RAM), Chromeleon (HPLC), New Brunswick BioCommand, and Softmax Pro plate readers.